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Methods for treating alzheimer's disease

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Methods for treating alzheimer's disease


Provided herein arc PAK inhibitors. Also provided herein are compositions and methods for treating an individual suffering from Alzheimer's disease.

Browse recent Afraxis, Inc. patents - La Jolla, CA, US
Inventors: Jay Lichter, Benedikt Vollrath, David Campbell, Sergio G. Durón
USPTO Applicaton #: #20120270844 - Class: 514154 (USPTO) - 10/25/12 - Class 514 
Drug, Bio-affecting And Body Treating Compositions > Designated Organic Active Ingredient Containing (doai) >Acyclic Nitrogen Double Bonded To Acyclic Nitrogen, Acyclic Nitrogen Triple Bonded To Acyclic Nitrogen Or Azide Doai >With An Additional Active Ingredient (excludes Reaction Product Or Complex)

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The Patent Description & Claims data below is from USPTO Patent Application 20120270844, Methods for treating alzheimer's disease.

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CROSS REFERENCE

This application claims priority to U.S. Provisional Application No. 61/250,350, entitled, “Methods for Treating Alzheimer\'s Disease,” filed on Oct. 9, 2009, the contents of which are incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

Alzheimer\'s disease (AD) is a progressive neurodegenerative disease characterized by progressive loss of cognition, and decreasing ability to control movement or bodily functions.

SUMMARY

OF THE INVENTION

Described herein are p21-activated kinase (PAK) inhibitors that halt or delay the progression of some or all symptoms of Alzheimer\'s disease (AD). In certain cases, Alzheimer\'s disease is initially diagnosed upon a finding of early dementia in the clinic. Progressive deterioration leads to moderate dementia and then advanced dementia in late stages of the disease. In some embodiments, the PAK inhibitors described herein halt or delay the progression of early stage Alzheimer\'s disease. In some embodiments, the PAK inhibitor described herein halt or delay the progression of middle stage Alzheimer\'s disease. In some embodiments, the PAK inhibitor described herein halt or delay the further deterioration in late stage Alzheimer\'s disease. In some embodiments, the PAK inhibitors described herein stabilize or alleviate or reverse symptoms of Alzheimer\'s disease. In some embodiments, PAK inhibitors described herein provide therapeutic benefit to an individual suffering from Alzheimer\'s disease that is non-responsive to conventional therapy (e.g., treatment with anticholinergics, antipsychotics or the like).

In some instances, PAK inhibition modulates spine morphogenesis. In some instances, PAK inhibitors modulate spine morphogenesis thereby modulating loss of synapses associated with Alzheimer\'s disease. In some instances, aberrant spine morphogenesis (e.g., abnormal spine density, length, thickness, shape or the like) is associated with pathogenesis of Alzheimer\'s disease. In some instances, administration of a PAK inhibitor to individuals diagnosed with or suspected of having Alzheimer\'s disease reduces, stabilizes or reverses abnormalities in dendritic spine morphology, density, and/or synaptic function, including but not limited to abnormal spine density, spine size, spine shape, spine plasticity, spine motility or the like. In some instances, administration of a PAK inhibitor to individuals diagnosed with or suspected of having Alzheimer\'s disease reduces, stabilizes or reverses depression of synaptic function caused by beta-amyloid protein.

Provided herein are methods for delaying or halting progression of Alzheimer\'s disease comprising administering to an individual in need thereof a therapeutically effective amount of a p21-activated kinase (PAK) inhibitor.

In some embodiments of the methods described herein, the Alzheimer\'s disease is early stage, middle stage or late stage Alzheimer\'s disease. In some embodiments, the Alzheimer\'s disease is associated with early dementia, moderate dementia or advanced dementia.

In some embodiments of the methods described herein, the p21-activated kinase (PAK) inhibitor modulates dendritic spine morphology or synaptic function.

In some embodiments, the p21-activated kinase (PAK) inhibitor modulates dendritic spine density. In some embodiments, the p21-activated kinase (PAK) inhibitor modulates dendritic spine length. In some embodiments, the p21-activated kinase (PAK) inhibitor modulates dendritic spine neck diameter. In some embodiments, the p21-activated kinase (PAK) inhibitor modulates dendritic spine shape. In some embodiments, the p21-activated kinase (PAK) inhibitor increases the number of mushroom-shaped dendritic spines. In some embodiments, the p21-activated kinase (PAK) inhibitor modulates dendritic spine head volume. In some embodiments, the p21-activated kinase (PAK) inhibitor modulates dendritic spine head diameter. In some embodiments, the p21-activated kinase (PAK) inhibitor modulates the ratio of the number of mature spines to the number of immature spines. In some embodiments, the p21-activated kinase (PAK) inhibitor modulates the ratio of the spine head volume to spine length.

In some embodiments, the p21-activated kinase (PAK) inhibitor modulates synaptic function. In some embodiments, the p21-activated kinase (PAK) inhibitor normalizes or partially normalizes aberrant baseline synaptic transmission associated with Alzheimer\'s disease. In some embodiments, the p21-activated kinase (PAK) inhibitor normalizes or partially normalizes aberrant synaptic plasticity. In some embodiments, the p21-activated kinase (PAK) inhibitor normalizes or partially normalizes aberrant long term depression (LTD) associated with Alzheimer\'s disease. In some embodiments, the p21-activated kinase (PAK) inhibitor normalizes or partially normalizes aberrant long term potentiation (LTP) associated with Alzheimer\'s disease. In some embodiments, the p21-activated kinase (PAK) inhibitor normalizes or partially normalizes deficits in memory, executive function, or language. In some embodiments, the p21-activated kinase (PAK) inhibitor reverses or partially reverses dementia or paraphasia.

In some embodiments of the methods described above, a therapeutically effective amount of a p21-activated kinase (PAK) inhibitor causes substantially complete inhibition of one or more p21-activated kinases. In some embodiments of the methods described above, a therapeutically effective amount of a p21-activated kinase (PAK) inhibitor causes partial inhibition of one or more p21-activated kinases.

In some embodiments, the p21-activated kinase (PAK) inhibitor is a Group I PAK inhibitor. In some embodiments, the p21-activated kinase (PAK) inhibitor is a PAK1 inhibitor. In some embodiments, the p21-activated kinase (PAK) inhibitor is a PAK2 inhibitor. In some embodiments, the p21-activated kinase (PAK) inhibitor is a PAK3 inhibitor.

In some embodiments, the methods described above further comprise administration of a second therapeutic agent. In some embodiments, wherein the second therapeutic agent is an acetylcholinestrase inhibitor, memantine or minocycline. In some embodiments, the second therapeutic agent is an alpha7 nicotinic receptor agonist. In some embodiments, the second therapeutic agent is a gamma secretase inhibitor. In some embodiments, the second therapeutic agent is a beta secretase inhibitor.

In some embodiments of the methods described above, administration of a p21-activated kinase (PAK) inhibitor to an individual in need thereof improves, stabilizes, or lessens the deterioration of scores on the Mini-Mental State Exam (MMSE) or Alzheimer Disease Assessment Scale-Cognitive (ADAS-cog) scale for the individual.

Provided herein are methods of reducing, stabilizing, or reversing neuronal withering and/or loss of synaptic function associated with Alzheimer\'s disease comprising administering to an individual in need thereof a therapeutically effective amount of an agent that modulates dendritic spine morphology or synaptic function.

In some embodiments, the neuronal withering and/or loss of synaptic function is induced by beta-amyloid protein, or proteolytic or hydrolysis products thereof, neurofibrillary tangles, amyloid tangles or hyperphosphorylated tau protein. In some embodiments, the neuronal withering or loss of synaptic function is associated with dimers or oligomers of beta-amyloid protein. In some embodiments, the dimers or oligomers of beta-amyloid protein are soluble in physiological fluids (e.g., cerebrospinal fluid, plasma, or the like). In some embodiments, the dimers or oligomers of beta-amyloid protein are insoluble in physiological fluids.

Also provided herein are methods of reducing, stabilizing or reversing atrophy or degeneration of nervous tissue in the brain associated with Alzheimer\'s disease comprising administering to an individual in need thereof a therapeutically effective amount of an agent that modulates dendritic spine morphology or synaptic function. In some embodiments, the atrophy or degeneration of nervous tissue is in the temporal lobe, the parietal lobe, the frontal cortex or the cingulate gyrus.

In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function modulates dendritic spine density. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function modulates dendritic spine length. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function modulates dendritic spine neck diameter. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function modulates dendritic spine shape. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function increases the number of mushroom-shaped dendritic spines. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function modulates dendritic spine head volume. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function modulates dendritic spine head diameter. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function modulates the ratio of the number of mature spines to the number of immature spines. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function modulates the ratio of the spine head volume to spine length.

In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function normalizes or partially normalizes aberrant baseline synaptic transmission associated with Alzheimer\'s disease. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function normalizes or partially normalizes aberrant synaptic plasticity. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function normalizes or partially normalizes aberrant long term depression (LTD) associated with Alzheimer\'s disease. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function normalizes or partially normalizes aberrant long term potentiation (LTP) associated with Alzheimer\'s disease. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function normalizes or partially normalizes deficits in memory, executive function, or language. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function reverses or partially reverses dementia or paraphasia. In some embodiments of the above methods, the agent that modulates dendritic spine morphology or synaptic function is a p21-activated kinase (PAK) inhibitor.

In some embodiments of any of the above methods, administration of a p21-activated kinase (PAK) inhibitor to an individual in need thereof improves, stabilizes, or lessens the deterioration of scores on the Mini-Mental State Exam (MMSE) or Alzheimer Disease Assessment Scale-Cognitive (ADAS-cog) scale for the individual.

Provided herein are methods for determination of an effective dose of a p21-activated kinase (PAK) inhibitor for treatment of Alzheimer\'s disease comprising:

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stats Patent Info
Application #
US 20120270844 A1
Publish Date
10/25/2012
Document #
13500293
File Date
10/08/2010
USPTO Class
514154
Other USPTO Classes
51425216, 5142342, 51426411, 51425211, 51425218, 514275, 5142358, 436 86
International Class
/
Drawings
5



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